EP3159006A1 - Pharmazeutische zusammensetzung zur verwendung in der prävention und/oder behandlung von krankheiten, die aufgrund der verringerung oder des verlusts der aktivität des blutgerinnungsfaktors viii und/oder des aktivierten blutgerinnungsfaktors viii entstehen oder voranschreiten - Google Patents

Pharmazeutische zusammensetzung zur verwendung in der prävention und/oder behandlung von krankheiten, die aufgrund der verringerung oder des verlusts der aktivität des blutgerinnungsfaktors viii und/oder des aktivierten blutgerinnungsfaktors viii entstehen oder voranschreiten Download PDF

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Publication number
EP3159006A1
EP3159006A1 EP15809216.3A EP15809216A EP3159006A1 EP 3159006 A1 EP3159006 A1 EP 3159006A1 EP 15809216 A EP15809216 A EP 15809216A EP 3159006 A1 EP3159006 A1 EP 3159006A1
Authority
EP
European Patent Office
Prior art keywords
coagulation factor
dose
blood coagulation
initial dose
polypeptide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP15809216.3A
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English (en)
French (fr)
Other versions
EP3159006A4 (de
Inventor
Koichiro YONEYAMA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chugai Pharmaceutical Co Ltd
Original Assignee
Chugai Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Priority to EP23157462.5A priority Critical patent/EP4218816A3/de
Publication of EP3159006A1 publication Critical patent/EP3159006A1/de
Publication of EP3159006A4 publication Critical patent/EP3159006A4/de
Withdrawn legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL

Definitions

  • the present inventors succeeded in discovering a more effective dosage regimen for a pharmaceutical composition containing a bispecific antigen-binding molecule that recognizes blood coagulation factor IX and/or activated blood coagulation factor IX and blood coagulation factor X and/or activated blood coagulation factor X for preventing and/or treating a disease that develops and/or progresses due to a decrease or deficiency in the activity of blood coagulation factor VIII and/or activated blood coagulation factor VIII.
  • antibody fragments and low-molecular-weight antibodies include diabodies (Dbs), linear antibodies, and single chain antibody (hereinafter, also denoted as scFv) molecules.
  • Dbs diabodies
  • scFv single chain antibody
  • an "Fv" fragment is a smallest antibody fragment and comprises a full antigen recognition site and binding site.
  • compositions of the present invention which are used for therapeutic or preventive purposes can be prepared by mixing, if necessary, with suitable pharmaceutically acceptable carriers, vehicles, and such and made into a freeze-dry formulation or a solution formulation.
  • suitable pharmaceutically acceptable carriers and vehicles include sterilized water, physiological saline, stabilizers, excipients, antioxidants (such as ascorbic acid), buffers (such as phosphate, citrate, histidine, and other organic acids), antiseptics, surfactants (such as PEG and Tween), chelating agents (such as EDTA), and binders.
  • initial dose refers to, for example, the dose used when a bispecific antigen-binding molecule of the present invention is administered to a patient for the first time.
  • the initial dose is within the range of approximately 0.001 mg/kg to approximately 100 mg/kg, and is for example, approximately 0.001 mg/kg, approximately 0.002 mg/kg, approximately 0.0025 mg/kg, approximately 0.003 mg/kg, approximately 0.004 mg/kg, approximately 0.005 mg/kg, approximately 0.006 mg/kg, approximately 0.007 mg/kg, approximately 0.0075 mg/kg, approximately 0.008 mg/kg, approximately 0.009 mg/kg, approximately 0.01 mg/kg, approximately 0.02 mg/kg, approximately 0.025 mg/kg, approximately 0.03 mg/kg, approximately 0.04 mg/kg, approximately 0.05 mg/kg, approximately 0.06 mg/kg, approximately 0.07 mg/kg, approximately 0.075 mg/kg, approximately 0.08 mg/kg, approximately 0.09 mg/kg, approximately 0.1 mg/kg, approximately 0.2 mg/kg
  • the initial dose is 10 mg/kg and at least one of the continued doses is 10 mg/kg and the administration interval is one week
  • the initial dose is 10 mg/kg and at least one of the continued doses is 3 mg/kg and the administration interval is one week
  • the initial dose is 10 mg/kg and at least one of the continued doses is 1 mg/kg and the administration interval is one week
  • the initial dose is 10 mg/kg and at least one of the continued doses is 0.3 mg/kg and the administration interval is one week
  • the initial dose is 10 mg/kg and at least one of the continued doses is 0.1 mg/kg and the administration interval is one week
  • the initial dose is 3 mg/kg and at least one of the continued doses is 3 mg/kg and the administration interval is one week
  • the initial dose is 3 mg/kg and at least one of the continued doses is 1 mg/kg and the administration interval is one week
  • the initial dose is 3 mg/kg and at least one of the continued doses is 0.3 mg/kg and the administration interval is one week
  • the initial dose
  • the dosage regimen is determined, for example, by considering the effects and safety. Furthermore, the dosage regimen is determined by considering the convenience of the patient, within the range that does not impair the effectiveness and safety. For example, the dosage regimen for a hemophilia A patient can be determined by considering the effects of preventing bleeding in patients and clinically acceptable safety.
  • the present invention provides a product comprising at least (i) a container; (ii) a pharmaceutical composition in a container, which comprises a bispecific antigen-binding molecule that recognizes blood coagulation factor IX and/or activated blood coagulation factor IX and blood coagulation factor X and/or activated blood coagulation factor X; and (iii) a document instructing administration of the antigen-binding molecule at an initial dose of approximately 0.001 to 100 mg/kg and multiple continued administrations of continued doses that are nearly the same as or less than the initial dose with administration intervals of at least one day or longer.
  • the number of bleedings per year (the Annualized Bleeding Rate (ABR)) is calculated as: (number of bleeding events x 365.25) / number of days of observation.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
EP15809216.3A 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur verwendung in der prävention und/oder behandlung von krankheiten, die aufgrund der verringerung oder des verlusts der aktivität des blutgerinnungsfaktors viii und/oder des aktivierten blutgerinnungsfaktors viii entstehen oder voranschreiten Withdrawn EP3159006A4 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP23157462.5A EP4218816A3 (de) 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur vorbeugung und/oder behandlung von krankheiten, die sich entwickeln oder vermehren aufgrund von blutgerinnungsfaktor viii und/oder aktiviertem blutgerinnungsfaktor viii

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2014127240 2014-06-20
JP2014226988 2014-11-07
PCT/JP2015/060171 WO2015194233A1 (ja) 2014-06-20 2015-03-31 血液凝固第ｖｉｉｉ因子および／または活性化血液凝固第ｖｉｉｉの活性の低下ないし欠損によって発症および／または進展する疾患の予防および／または治療に用いられる医薬組成物

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP23157462.5A Division EP4218816A3 (de) 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur vorbeugung und/oder behandlung von krankheiten, die sich entwickeln oder vermehren aufgrund von blutgerinnungsfaktor viii und/oder aktiviertem blutgerinnungsfaktor viii

Publications (2)

Publication Number Publication Date
EP3159006A1 true EP3159006A1 (de) 2017-04-26
EP3159006A4 EP3159006A4 (de) 2018-01-03

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EP15809216.3A Withdrawn EP3159006A4 (de) 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur verwendung in der prävention und/oder behandlung von krankheiten, die aufgrund der verringerung oder des verlusts der aktivität des blutgerinnungsfaktors viii und/oder des aktivierten blutgerinnungsfaktors viii entstehen oder voranschreiten
EP23157462.5A Pending EP4218816A3 (de) 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur vorbeugung und/oder behandlung von krankheiten, die sich entwickeln oder vermehren aufgrund von blutgerinnungsfaktor viii und/oder aktiviertem blutgerinnungsfaktor viii

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP23157462.5A Pending EP4218816A3 (de) 2014-06-20 2015-03-31 Pharmazeutische zusammensetzung zur vorbeugung und/oder behandlung von krankheiten, die sich entwickeln oder vermehren aufgrund von blutgerinnungsfaktor viii und/oder aktiviertem blutgerinnungsfaktor viii

Country Status (16)

Country Link
US (10) US20170253663A1 (de)
EP (2) EP3159006A4 (de)
JP (2) JP6663846B2 (de)
KR (2) KR20170015517A (de)
CN (1) CN106559987A (de)
AU (1) AU2015275440B2 (de)
BR (1) BR112016029316A2 (de)
CA (1) CA2951622C (de)
IL (1) IL249330B (de)
MX (1) MX2016016380A (de)
MY (1) MY189333A (de)
RU (1) RU2721910C2 (de)
SG (2) SG10201811185YA (de)
TW (2) TW201625299A (de)
WO (1) WO2015194233A1 (de)
ZA (1) ZA201700459B (de)

Cited By (2)

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WO2019096874A1 (en) * 2017-11-15 2019-05-23 Novo Nordisk A/S Factor x binders enhancing fx activation
EP3509637A4 (de) * 2016-09-06 2020-05-27 Chugai Seiyaku Kabushiki Kaisha Verfahren zur verwendung eines bispezifischen antikörpers mit erkennung des gerinnungsfaktors ix und/oder aktivierten gerinnungsfaktors ix und gerinnungsfaktors x und/oder aktivierten gerinnungsfaktors x

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TW202207984A (zh) * 2019-10-11 2022-03-01 日商中外製藥股份有限公司 用於後天性血友病a之預防及/或治療之醫藥組成物、及包含該醫藥組成物之製品
KR20230130560A (ko) 2022-03-02 2023-09-12 노보 노르디스크 헬스 케어 악티엔게젤샤프트 Fviii 모방 이중특이적 항체의 주 1회 투여 방법
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3509637A4 (de) * 2016-09-06 2020-05-27 Chugai Seiyaku Kabushiki Kaisha Verfahren zur verwendung eines bispezifischen antikörpers mit erkennung des gerinnungsfaktors ix und/oder aktivierten gerinnungsfaktors ix und gerinnungsfaktors x und/oder aktivierten gerinnungsfaktors x
US11352438B2 (en) 2016-09-06 2022-06-07 Chugai Seiyaku Kabushiki Kaisha Methods of using a bispecific antibody that recognizes coagulation factor IX and/or activated coagulation factor IX and coagulation factor X and/or activated coagulation factor X
WO2019096874A1 (en) * 2017-11-15 2019-05-23 Novo Nordisk A/S Factor x binders enhancing fx activation
CN111386285A (zh) * 2017-11-15 2020-07-07 诺沃挪第克公司 增强fx活化的因子x结合物
US11787874B2 (en) 2017-11-15 2023-10-17 Novo Nordisk A/S Factor X binders enhancing FX activation

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MY189333A (en) 2022-02-04
US20240317891A1 (en) 2024-09-26
TW202241504A (zh) 2022-11-01
RU2017101705A (ru) 2018-07-27
CA2951622C (en) 2023-01-03
IL249330A0 (en) 2017-02-28
TW201625299A (zh) 2016-07-16
US20220324999A1 (en) 2022-10-13
IL249330B (en) 2021-07-29
US20200407463A1 (en) 2020-12-31
ZA201700459B (en) 2021-07-28
RU2017101705A3 (de) 2018-11-01
MX2016016380A (es) 2017-04-06
US20240052060A1 (en) 2024-02-15
JP6663846B2 (ja) 2020-03-13
KR20240063162A (ko) 2024-05-09
KR20170015517A (ko) 2017-02-08
US20230174673A1 (en) 2023-06-08
US20210238307A1 (en) 2021-08-05
CN106559987A (zh) 2017-04-05
JP2020055864A (ja) 2020-04-09
WO2015194233A1 (ja) 2015-12-23
EP3159006A4 (de) 2018-01-03
CA2951622A1 (en) 2015-12-23
RU2721910C2 (ru) 2020-05-25
TWI831106B (zh) 2024-02-01
US20200157243A1 (en) 2020-05-21
EP4218816A3 (de) 2023-09-13
SG11201610581RA (en) 2017-01-27
BR112016029316A2 (pt) 2018-02-20
NZ727218A (en) 2023-08-25
JPWO2015194233A1 (ja) 2017-04-20
US20190309090A1 (en) 2019-10-10
EP4218816A2 (de) 2023-08-02
US20170253663A1 (en) 2017-09-07
AU2015275440A1 (en) 2017-01-12
SG10201811185YA (en) 2019-01-30
US20220073645A1 (en) 2022-03-10
AU2015275440B2 (en) 2020-07-16

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